Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy
Irinotecan is a camptothecin analog which exerts its cytotoxic effects by forming a covalent
complex with topoisomerase I and DNA, resulting in inhibition of DNA re-ligation,
accumulation of DNA double strand breaks and apoptotic cell death (1). Irinotecan is FDA
approved for use in the front-line and second-line treatment of colorectal cancer. It has
also demonstrated activity in a variety of other non-hematologic tumors. The recently
updated ASCO antiemetic guidelines characterize irinotecan as having moderate emetic risk.
(2). However, the emetogenic potential of this agent has been poorly characterized and there
are no published prospective trials with emesis as a primary-end point. In addition there is
a complete paucity of information on the potential of irinotecan to induce emesis beyond the
first day after chemotherapy, so-called delayed emesis. Best characterized following
cisplatin, delayed emesis is also associated with a number of other chemotherapy agents that
similar to irinotecan appear to be moderately emetogenic such as carboplatin,
cyclophosphamide and doxorubicin. Antiemetic prophylaxis for delayed emesis following
irinotecan is not routinely prescribed at the present time. Prospectively obtained
information on the potential of irinotecan to cause delayed emesis would be helpful in
guiding appropriate antiemetic practice.
Observational Model: Case-Only, Time Perspective: Prospective
frequency of delayed emesis (vomiting/retching)
days 2 - 5
Paul J Hesketh, M.D.
Steward St. Elizabeth's Medical Center of Boston, Inc.
United States: Institutional Review Board
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